Method for filling a syringe

ABSTRACT

An apparatus and method for preventing foreign material from entering syringes during the filling of the syringes from containers and thus preventing foreign material from being injected into a patient. The apparatus provides a liquid container, such as a vial, having a pierceable self-sealing stopper for inserting the syringe needle for filling the syringe. A filter material is attached to the top of the container so that the needle can be extended therethrough and adapted to filter out foreign material such as coring that breaks loose as the needle pierces the top of the container. A method is provided including drawing air into a syringe prior to inserting the syringe cannula through a pierceable self-sealing stopper of a container. The air in the syringe is then injected into the container freeing any coring material that has broken from the container stopper either into the filtering material or into the liquid in the container. The cannula tip is then withdrawn or extended to place the tip either in the liquid or the filter material where the coring material has not been deposited and drawing the required amount of liquid from the container into the syringe.

United States Patent [72] lnventor Thomas J. Flynn 112 White Cap Ave.. Daytona Beach, Fla. 32018 [21 1 Appl. No. 857,089

[22] Filed Sept. 11,1969

[45] Patented May 11, 1971 [54] METHOD FOR FILLING A SYRINGE l28/(lnquired), 218 (M), 272; 141/1, 2, 3, 18-29, 286, 329, 330; 220/(lnquired);

222/(lnquired) [56] ReferencesCited UNITED STATES PATENTS 1,178,512 4/1916 Garlock 141/23 Pn'mary Examiner-Houston S. Bell, Jr. Attorney-Duckworth & Hobby ABSTRACT: An apparatus and method for preventing foreign material from entering syringes during the filling of the syringes from containers and thus preventing foreign material from being injected into a patient. The apparatus provides a liquid container, such as a vial, having a pierceable self-sealing stopper for inserting the syringe needle for filling the syringe. A filter material is attached to the top of the container so that the needle can be extended therethrough and adapted to filter out foreign material such as coring that breaks loose as the needle pierces the top of the container. A method is provided including drawing air into a syringe prior to inserting the syringe cannula through a pierceable self-sealing stopper of a container. The air in'the syringe is then injected into the container freeing any coring material that has broken from the container stopper either into the filtering material or into the liquid in the container. The cannula tip is then withdrawn or extended to place the tip either in the liquid or the filter material where the coring material has not been deposited and drawing the required amount of liquid from the container into the syringe.

PATENTEU'HAYHIHYI H 3,578,037

INV NTOR.

METHOD FOR FILLING A SYRINGE BACKGROUND OF THE INVENTION I. Field of the Invention The present invention relates to containers, vials and other bottles, and the like, having pierceable self-sealing-type stoppers or tops adapted for easy filling of syringes by inserting the needles through the stoppers into the containers and more particularly to the method and apparatus utilized in filling syringes in a manner to prevent coring material or fine pieces of the stopper for the containers from entering the syringes and being injected into the patients. Coring" is a term used in the medical profession to indicate small pieces of rubber that are cut or broken loose when the needle or cannula of a syringe is pushed through the rubber stopper on the top of a container. This piece of rubber or core is usually forced into the liquid in the container or vial and then may enter the syringe along with the liquid when the syringe is filled. Thus a small core can be pulled into the syringe and injected into the patient, especially in the case of multiple-dose vials or containers where many penetrations of the rubber stopper are expected. The problem of coring has plagued the industry for many years and has resulted in many suggestions to remedy the problem.

2. Description of the Prior Art In the past, a number of suggestions have been made for remedying the coring problem and also for filtering liquids. These prior art approaches include primarily studies of the type of material used for the stopper to find a material that is less likely to provide a coring action, aswell as a study of the thickness and shape of the stopper in order to provide a combination of ingredients in the stopper to reduce the amount of coring and the amount of foreign materials that can get into a vial. It has also been suggested in the pastto use various types of pressure to force the stopper into the vial to reduce the coring as well as to change the shape of the needle tip cutting edge of the needle to reduce the coring action. While these various approaches have improved and reduced the coring problem, they have not to date been successful in eliminating it and there apparently has been only one successful way that a core-free injection can be obtained prior to my invention. This is performed by using a very costly filtered needle for injection into the patient but the increased cost of this'needle makes it uneconomical, especially in view of the trend toward using disposable syringes and needles, which disposable syringes are not only convenient but provide a solution to the sterilization problem, especially as relates to viruses such as hepatitis that may be transmitted by reusable needles.

It has also been suggested in the past to provide various types of combinations or syringes and vials which are either disposable or may be reloaded and maintained as a combination vial, syringe and needle. Thus a physician who has to carry a hypodermic syringe along with the injection material, antiseptic and absorbent material with him for a specific injection, can have the syringe and injection liquid and container combination put together in a manner as not to damage the needle in transit and sometimes even to incorporate absorbent material and antiseptic in a combination unit.

It has also been suggested to have stoppered tops with absorbent material in a chamber therein, which chamber is adapted to allow sterilized air to enter into the container to replace the space from the removal of part of the liquid into the syringe.

Finally, one prior art US. Pat. No. 2,585,938, has suggested a bottle seal having a filter in the bottle or container in which sterile blood is kept for use in blood transfusions. This prior art filter is in the form of a hollow tube inside of a container with an open mouth sealed against the inner surface of a stopper, with indicia on the outer surface of the stopper to indicate the location for inserting the needle so'that it will enter into the hollow space in the filter. While this prior art filter is desirable for use with transfusions of blood to remove clotting material, and the like, it would of course not be satisfactory for filtering coring material since the liquid is withdrawn from the same hollow chamber in which it had been inserted leaving the coring material in a position to be even more likely to be transferred to the patient.

Accordingly, it is an object of my invention to provide an economical, anticoring device and method from which foreign matter and coring material may be prevented from being injected into a patient in a very inexpensive manner even when used with the multiple-dose vials while allowing disposable syringes and needles to be utilized in giving injections.

SUMMARY OF THE INVENTION An apparatus and method are provided for preventing foreign particles such as coring material from being accidentally injected into a patient. A liquid container or vial is provided having a pierceable self-sealing stopper adapted for piercing with a needle or cannula of a syringe during filling of the syringe prior to giving an injection to a patient. The selfsealing stopper has a filter fixedly attached to the stopper and inside the liquid container and extending into the container whereby a syringe needle when inserted through the self'sealing stopper may be extended through the filter into a liquid for filling, or ,may be retracted into the filter for filling with the liquid in a container. A method for filling a syringe is provided which includes the steps of drawing air into the syringe in the approximate amount of the liquid to be withdrawn into the syringe then inserting the cannula of the syringe through a pierceable, self-sealing stopper or top of a liquid-containing container, injecting the air from the syringe into the container thereby expelling any coring material or foreign matter that may have gotten into the syringe needle either into the mass of a filter material or,directly into one or the other side of the filter material thereby isolating the foreign material either in the filter or to one side or the other of the filter. The needle tip is positioned into the filter material or to either side thereof but otherwise than where the foreign matter has been expelled from the syringe needle or broken off from the rubber stopper and finally drawing liquid in the container into the syringe in a position isolated from the foreign matter expelled or broken off.

BRIEF DESCRIPTION OF THE DRAWING Other objects, features and advantages of this invention will be apparent from a study of the written description and the drawings in which:

FIG. 1 shows a sectional view of one embodiment of the present invention;

FIG. 2 shows a view taken along line 2-2 of FIG. 1; and

FIG. 3 shows an exploded view of the top portion of the container of FIGS. 1 and 2.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIG. 1, there can be seen a liquid container or vial 10 held in a mans hand 11 and having a stopper cover or seal 12 for holding the stopper 13 within the container I0. Stopper 13 maintains a liquid 14 within the container 10 in a manner to prevent the liquid from leaking out and also to prevent ingress into the container of contaminations. Container 10 would typically be a glass container while stopper 13 would be a special rubber or synthetic resilient material especially adapted for use as stoppers for vials that hold medicine and sealing member 12 could typically be a metallic seal such as aluminum. A hypodermic syringe I5can be seen having a needle or cannula 16 extending therefrom and through the rubber stopper 13 into the liquid container I0. The needle 10 has a portion 17 which typically has a cutting edge so that it may easily pierce the stopper 13 in container I0 and also easily pierce the skin and flesh of a patient .being injected with the syringe l5. Syringe I5 is shown being held by hand 9 pushing a finger plate or handle 18 which is adapted to operate a piston or plunger 19 for filling the syringe or injecting the liquid in the syringe into a patient. Container 10 stopper 13 can be seen to have a filter 20, such as may be a foamed plastic material, which is especially adapted for filtering out small particles of foreign matter that may enter into the container 10. Filter 20 can be seen to be connected to stopper 13 and extending into container 10 a short distance relative to the larger tubular length of container 10. in a typical operation for injecting a patient, the syringe 15 might be filled with air in approximately the same volume as the liquid injection medicine 14 that is to be injected into the patient. The syringe is inserted through rubber stopper 13 which is a self-sealing pierceable stopper and into container 10. The air in syringe 15 is injected into the container 10 and the desired amount of liquid 14 withdrawn into syringe 15 for injection into a patient. The syringe needle would then be withdrawn from the container and injected into the patient. However, one of the problems experienced in this operation is that small pieces of stopper 13 break off inside the container when the needle 16 is inserted therethrough, resulting in small bits of foreign matter entering the liquid 14 which may then be drawn into the syringe l and injected into a patient accidentally. In addition to coring material other foreign matter may also accidentally get into the container 10. This problem is especially troublesome in multiple injection vials in which small pieces of coring material may accumulate and increase the probability of accidentally getting a piece of material in the needle 16 or syringe 15 and injecting the material into the patient. It is ac cordingly desirable to have a stopper 13 made of a material that is both inert to the medicine 14 while having desirable anticoring characteristics.

Turning now to FIG. 2, there can be seen a view taken along line 2-2 of FIG. 1 showing a portion of container having a liquid 14 therein maintained in the container 10 by stopper 13 which has a sealing member 12 for assuring that the stopper 13 is not removed and is held tightly in place in the container 10. A portion 21 of stopper 13 can be seen to be not covered by the winding 12 so that needle 16 can be easily pierced through stopper 13 for withdrawing liquid 14 into the syringe. An arcuate portion 26 of the stopper 13 provides the stopper with desirable anticoring characteristics while leaving a space 22 located within the general confines of the stopper 13. Filter material 20 is illustrated as an inorganic flexible cellular material such as a foamed resilient polyurethane plastic which must be desirably inert to the liquid 14 while acting as a filter to filter out or hold foreign particles such as coring material. Filter 20 is held to stopper 13 by a heat seal at surface 23 connecting the rim 24 of stopper 13 to filter 20 thus leaving the space 22 totally enclosed on one side of the filter 20.

With reference to FIGS. 1 and 2, the following embodi' ments of my method for filling a syringe are provided. The syringe may be filled with air or other gas as desired in approximately the same volume as liquid 14 that is to be withdrawn from container 10 for injection into a patient. The needle portion 16 of the syringe 15 is then inserted through stopper 13 into container 10 where it could pick up a piece of coring material in the cutting end 17 of the needle 16 or the coring material could break off directly into space 22. Needle 16 could be extended past filter and the air injected into the container 10 which would inject any foreign material therein into the liquid 14. The tip 17 of needle 16 could then be withdrawn into filter 20 prior to the step of withdrawing the desired amount of the medicine 14 froma zone isolated from that of where the coring material was injected or broke off in container 10 whereby the syringe 15 is filled substantially free of foreign matter or coring material. Alternatively, the needle tip 17 could originally be inserted into the area 22 or into filter 20 and in these zones inject the air from syringe 15 into container 10 thus trapping any foreign particles or coring material either in the isolated portion 22 or within the filter material 20 then pushing the tip 17 of needle 16 further into container 10 into the open area of liquid 14 and filling any desired amount whereby foreign matter is again isolated from the needle tip 17 and from entering into the syringe 15 thus protecting patients from havin foreign materials injected into them.

FIG. 3 s ows an exploded view with the top or lip of bottle 25 or bottle 10 being visible with the stopper 13 being removed therefrom along with the sealing member 12 which desirably is wrapped around stopper 13 top and around lip 25 of container 10 when the container is filled. The filtering material 20 can be seen heat sealed to stopper 13 at 23. It will of course be clear that material 20 can be varied as well as can be the means for connecting material 20 to the stopper 13 without departing from the spirit and scope of the invention. The filter 20 by preventing coring materials from entering the bottle may allow top 13 arcuate portion 26 to be changed.

It will of course be clear that an anticoring method and apparatus have been provided for the inexpensive prevention of foreign materials from being injected into patients but this invention is not to be construed as limited to the particular forms disclosed herein since these are to be regarded as illustrative rather than restrictive.

lclaim:

1. A method for filling a syringe from a container of liquid comprising in combination the steps of:

a. drawing gas into said syringe;

b. inserting the needle of said syringe through a pierceable self-sealing stopper located in an opening to said container;

c. injecting gas in said syringe into said container thereby expelling any foreign material from said needle in one area of said container;

d. locating the tip of said needle in a second area of said container separated from said one area by a filtering material; and

e. drawing liquid from said container into said syringe.

2. The method according to claim 1 in which said locating said needle tip in one area includes locating said needle tip within a filter material.

3. The method according to claim 1 in which said locating said needle tip in one area includes locating said needle tip to one side of a filter material.

4. The method according to claim 1 in which said gas drawn into said syringe is air having a volume in approximately the same volume of liquid that is to be drawn from said container into said syringe. 

1. A method for filling a syringe from a container of liquid comprising in combination the steps of: a. drawing gas into said syringe; b. inserting the needle of said syringe through a pierceable self-sealing stopper located in an opening to said container; c. injecting gas in said syringe into said container thereby expelling any foreign material from said needle in one area of said container; d. locating the tip of said needle in a second area of said container separated from said one area by a filtering material; and e. drawing liquid from said containEr into said syringe.
 2. The method according to claim 1 in which said locating said needle tip in one area includes locating said needle tip within a filter material.
 3. The method according to claim 1 in which said locating said needle tip in one area includes locating said needle tip to one side of a filter material.
 4. The method according to claim 1 in which said gas drawn into said syringe is air having a volume in approximately the same volume of liquid that is to be drawn from said container into said syringe. 